Clinical trial
Prospective Pilot Study Evaluating the Efficacy of Low-Dose Topical Steroids in Maintaining Histologic Remission of Eosinophilic Esophagitis in Children
Name
2014-15753
Description
This study evaluates the decrease in steroid dosing for patients who have achieved remission on a full dose of steroids. Once a patient is in remission they will be enrolled in this study if they choose to decrease the steroid dosing.
Trial arms
Trial start
2014-05-01
Estimated PCD
2024-05-01
Trial end
2025-05-01
Status
Active (not recruiting)
Treatment
Dose
We are looking at the outcomes of prescribing half of the topical steroid (i.e. fluticasone \[Flovent\] and Swallowed viscous budesonide \[Pulmicort\]) in relation to the patient's remission. These patients will have already achieved remission on a full dose of the steroid.
Size
50
Primary endpoint
Efficacy of Low Dose Topical Steroid
At standard of care endoscopies from the date of enrollment; estimated every 6-12 months
Eligibility criteria
Inclusion Criteria:
* Patients diagnosed with EoE
* Patients less than 21 years of age at enrollment
* Patients who within the past 12 months have demonstrated histologic remission (\<15 eos/hpf as assessed by upper esophagogastroduodenoscopy (EGD) with biopsy ) to the standard induction dose of topical steroids and have remained on this treatment:
* Topical steroid treatment includes only those with previously published results: Swallowed topical fluticasone (i.e. Flovent®), and Swallowed viscous budesonide (i.e. Pulmicort Respules®) mixed with Honey or Splenda®
* Patients who are interested in lowering their dose of topical steroids.
Exclusion Criteria:
* Patients with EoE who have not demonstrated histologic remission (\<15 eos/hpf) to topical steroids.
* Patients who are unable or unwilling to take topical steroids.
* Patients who have changed the vehicle or carrier (e.g. Splenda®or honey ) used to mix with the actual steroid drug, after demonstrating histologic remission.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '2 Years', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2023-09-01
1 organization